Label: PROMETHAZINE HYDROCHLORIDE tablet

  • NDC Code(s): 65841-040-01, 65841-040-05, 65841-040-10, 65841-041-01, view more
    65841-041-05, 65841-041-10, 65841-042-01, 65841-042-05, 65841-042-10
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2024

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-040-01 in bottle of 100 tablets

    Promethazine Hydrochloride Tablets USP, 12.5 mg

    Rx only

    100 tablets

    Promethzine Tablets, 12.5 mg

    NDC 65841-041-01 in bottle of 100 tablets

    Promethazine Hydrochloride Tablets USP, 25 mg

    Rx only

    100 tablets

    Promethazine Tablets, 25 mg

    NDC 65841-042-01 in bottle of 100 tablets

    Promethazine Hydrochloride Tablets USP, 50 mg

    Rx only

    100 tablets

    Promethazine Tablets, 50 mg
  • INGREDIENTS AND APPEARANCE
    PROMETHAZINE HYDROCHLORIDE 
    promethazine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;01
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-040-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    2NDC:65841-040-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    3NDC:65841-040-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059612/14/2005
    PROMETHAZINE HYDROCHLORIDE 
    promethazine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code Z;C;0;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-041-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    2NDC:65841-041-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    3NDC:65841-041-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059612/14/2005
    PROMETHAZINE HYDROCHLORIDE 
    promethazine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC03
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-042-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    2NDC:65841-042-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    3NDC:65841-042-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04059612/14/2005
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited677605858ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042)
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